Device recalls

Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as foll…

Medline Industries, LP · Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result…

Open, ClassifiedUnder Investigation by firmZ-1714-2026
Open FDA's page for this record
Cfres ID
219147
Product res number
Z-1714-2026
Event date initiated
2026-02-27
Event date posted
2026-04-07
Recall status
Open, Classified
Res event number
98598
Product code
OGJ
Firm FEI number
1417592
Recalling firm
Medline Industries, LP
Address 1
3 Lakes Dr
City
Northfield
State
IL
Postal code
60093-2753
Additional info contact
Haley Barclay 866-359-1704
Root cause description
Under Investigation by firm
Product quantity
3120 kits
Product description

Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: CVOR ANGIOGRAPHY PACK-LF, Medline SKU DYNJ42367B

Code info

Medline SKU DYNJ42367B UDI/DI each 10193489211511, UDI/DI case 40193489211512, Lot Numbers: 24FBJ579, 24DBL828, 24DBE055, 24CBG967, 24ABN254, 23LBI540, 23KBF222, 23JBM761, 23JBA270, 23HBY791, 23HBD212, 23GBJ794, 23FBK893, 23EBQ313, 23DBC465.

Reason for recall

Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

Action

Medline Industries, LP issued an "URGENT MEDICAL DEVICE RECALL" notice to its consignees on 2/27/2026 via USPS and email. The notice explained the issue, risk associated with syringe disconnection and loose connection, and request customers remove and destroy all Namic RA Syringes. Over-labels will be provided for any affected kits on hand stating that the affected syringes must be removed and discarded from further use. The only exception is in rare circumstances where angiography is urgently required, no alternative device is available, and postponing the procedure would place the patient at significant risk. Required Action: Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.

Distribution pattern

Worldwide distribution: US (nationwide) including Puerto Rico (PR) and OUS (foreign) to countries of: Canada (CA), Netherlands (NL), Australia (AU), Korea, Republic of (KR), Sri Lanka (LK), Pakistan (PK), Japan (JP), United Arab Emirates (AE), Singapore (SG) and Slovakia (SK).

Harmonized identifiers (openFDA)
Device name
Nerve Block Tray
Medical specialty description
Anesthesiology
Regulation number
868.5140
Device class
2
Registration number
3009888344, 2433012, 1928237, 1223004, 1018470, 3015173212, 1055236, 1047429, 3005012805, 3045816902, 3005595283, 3006450239, 1423537, 3004076349, 1043214, 1061927, 2029015, 9616088, 2523676, 3013764800, 3035642068, 8022210, 3004111573, 1423395, 1625425, 1643817, 3045816907, 2245270, 3007329020, 1054241, 1030451, 1061124, 3008552585, 2521402, 1420054
FEI number
3009888344, 2433012, 1928237, 1000112968, 1000160458, 3932, 1018470, 1000512168, 3015173212, 1047429, 3005012805, 3002902735, 3045816902, 1000112877, 3005595283, 3006450239, 3004076349, 1043214, 1000120555, 3000717925, 3000203000, 2523676, 3013764800, 3035642068, 3004111573, 3001236905, 1625425, 1643817, 3045816907, 2245270, 3007329020, 1030451, 3008552585, 2521402, 1420054
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.